Kornimate/medical-research-clean huggingface dataset:
a 24 week, multicenter, open, evaluation of the clinical effectiveness of the once-daily 10 cm^2 rivastigmine patch formulation in patients with probable alzheimer's disease (extra)

Conditions: Alzheimer's Disease

Summary: this study is designed to confirm the efficacy, the tolerability, the patient compliance and the caregiver satisfaction with rivastigmine target patch size 10 cm\^2 in patients with probable alzheimer's disease (mini-mental state examination 10-26) in the community setting


Eligibility criteria:
inclusion criteria: * males, and females of at least 50 years old with a primary caregiver * probable alzheimer's disease * mini-mental state examination (mmse) score of ≥ 10 and ≤ 26 * patients initiating therapy for the first time with a cholinesterase (che) inhibitor (patients prescribed both rivastigmine and memantine are allowed) or patients who failed to benefit from previous che inhibitor treatment * residing with someone in the community throughout the study or, if living alone, in contact with the responsible caregiver everyday exclusion criteria: * patients not treated according to the product monograph for capsules * current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application) * history of allergy to topical products containing any of the constituents of the patches other protocol-defined inclusion/exclusion criteria may apply.

Keywords: alzheimer's disease cholinesterase inhibitor rivastigmine
post-marketing surveillance on long-term drug use of kiklin (bixalomer)® capsules in patients with hyperphosphatemia receiving peritoneal dialysis

Conditions: Chronic Renal Failure

Summary: to evaluate the safety and efficacy of long-term use of kiklin® capsules in actual clinical settings.


Eligibility criteria:
inclusion criteria: * chronic renal failure patients with hyperphosphatemia receiving peritoneal dialysis

Keywords: peritoneal dialysis bixalomer chronic renal failure patients with hyperphosphatemia kiklin®
the impact of covid-19 pandemic on thyroid surgery in italy: results from a nation-wide multicentric study

Conditions: Thyroid Disease

Summary: italy has been on the frontline of the covid-19 pandemic, caused by the coronavirus sars-cov-2, the need to focus resources to deal with the pandemic led to a disruption of routine surgical care, as well as activity for oncologic and chronic disease. the aim of this study was to evaluate the impact of covid-19 pandemic on surgical activity of the italian units of endocrine surgery belonging to the siuec (italian society of endocrine surgery), the most important national scientific society of endocrine surgery.the aim of this study was to evaluate the impact of covid-19 pandemic on surgical activity of the italian units of endocrine surgery belonging to the siuec (italian society of endocrine surgery), the most important national scientific society of endocrine surgery.


Eligibility criteria:
inclusion criteria: * patients that had undergone thyroidectomy during covid-19 pandemic (from the 9th march to the 31st august 2020), defined as case group, or during the same period of the previous year (from the 9th match to the 31st august 2019), defined as control group. exclusion criteria: * incomplete data
core: study to evaluate the conducted af-response-algorithm in patients suffering from heart failure and atrial fibrillation

Conditions: Heart Failure; Sudden Cardiac Death; Atrial Fibrillation

Summary: the medtronic insync iii marquis cardiac resynchronization therapy defibrillator (crt-d)-system (implantable cardioverter-defibrillator with biventricular stimulation for cardiac resynchronization) is equipped with the "conducted-atrial fibrillation (af)-response-algorithm (cafr)". this algorithm is designed to maximize biventricular stimulation and thus the amount of cardiac resynchronization when atrial fibrillation occurs. the goal of the study is the evaluation of the effect of the cafr in crt-patients suffering from atrial fibrillation by quantification of the increase of biventricular pacing during atrial fibrillation caused by cafr as well as the influence of the cafr on the ventricular heart rate.


Eligibility criteria:
inclusion criteria: * implant of a medtronic insync iii marquis (7279) or later system with conducted af-response exclusion criteria: * medical reasons that are adverse to participation in the study and compliance by the patient * patients who are enrolled in another study or plan to be enrolled into another study * pregnant patients or patients who are possibly pregnant due to an unreliable form of contraception

Keywords: heart failure primary prevention of sudden cardiac death secondary prevention of sudden cardiac death cardiac desynchronization crt-d cardiac dyssynchrony
patient controlled administration of liquid acetaminophen

Conditions: Pain; Pain, Postoperative

Summary: this is a proof of concept pilot study investigating the feasibility and acceptability of patient controlled oral medication administration, using the commonly used and low risk medication in the hospital, oral acetaminophen.

the primary objective of this prospective pilot study is to determine the feasibility of patient-controlled administration of liquid oral acetaminophen using recruitment rate and adherence to the study protocol rate as surrogate markers. investigators hypothesize that patients will accept the new concept of self-controlled oral administration of liquid acetaminophen, with more than 50% patient enrollment rate and less than 20% withdrawal rate from the study group to the traditional nurse-administered acetaminophen pills. the secondary objective of this study is to determine the preliminary efficacy of patient-controlled delivery of oral acetaminophen administration. if the medication is spilled or otherwise not dispensed correctly, the patients will be instructed to report this instantly to the nurse. the nurse will document and provide a replacement. all study participants have the option to call the nurse for assistance with break through pain. in addition, there is a call button to call for help with any other needs or discomfort. all other medications, such as nsaids or oral opioids, will be administered as prescribed. participants will have to fill out a paper questionnaire and keep a pain diary, and nurses will have to fill out a questionnaire.

Eligibility criteria:
inclusion criteria: participants * adult patients older than 18 years old admitted to src for total shoulder and reverse total shoulder arthroplasty nurses * the nurse who will administer acetaminophen to a study patient. exclusion criteria: participants * pregnant patient * patients that cannot swallow pills or cannot take liquid (for example due to risk of aspiration) * emergency surgery * chronic pain * on home opioids, any other pain modulating medications including benzodiazepine, neurontin, ketamine. * past medical or social history of substance abuse disorder, including ethanol misuse disorder, marijuana misuse disorder * history of any psychiatric disorders including anxiety, depression, any cognitive dysfunction * any patients who cannot provide informed consents on their own (those who would need legally authorized representatives (lars) or surrogates) * liver dysfunction limiting amount of safe oral acetaminophen * baseline hyperbilirubinemia (ex: chronic liver disease, gilbert's) * patients unable to take po * patients with neurologic, neuromuscular, or movement disorders unable to drink from a cup. nurses * any nurse who is not involved in the direct care of a study patient, or who is not comfortable with setting up the pca pump.

Keywords: pain management
the abcdef bundle in critical care: a french national survey still a long way to go!

Conditions: Delirium

Summary: the goal of this observational study is to evaluate the knowledge and compliance of french intensive care units with the abcdef (a: assessment, prevention, management of pain, b: both spontaneous awakening trials and spontaneous breathing trials, c: choice of sedation and analgesia, d: delirium assessment, prevention, and management, e: early mobility and exercise, f: family engagement and empowerment) bundle. french icu doctors will be asked to answer a questionnaire available online.


Eligibility criteria:
inclusion criteria: french icu doctors

Keywords: abcdef bundle, icu delirium, sedation, exercise, family
safety and effectiveness of nicvax in treating nicotine dependent individuals

Conditions: Smoking Cessation; Tobacco Use Cessation

Summary: nicotine is highly addictive and many individuals are unable to quit smoking even with treatment. the purpose of this study is to determine the effectiveness of various doses of nicvax in treating nicotine dependent individuals.

tobacco use is the single leading preventable cause of death in the united states. nicotine is an alkaloid that is derived from the tobacco plant responsible for the psychoactive and addictive effects of smoking. immunotherapy may be useful in preventing and treating nicotine dependent individuals. nicvax is a nicotine vaccine, a type of immunotherapy that may be effective in smoking cessation and preventing relapse to nicotine. the purpose of this study is to evaluate the safety and efficacy of various dosing levels and dosing frequencies of nicvax in treating nicotine dependent individuals.

Eligibility criteria:
inclusion criteria: * current smoker * good general health, including mental health * alveolar carbon monoxide level greater than or equal to 10 ppm exclusion criteria: * prior exposure to nicvax * known allergy to any of the components of nicvax * use of any smoking cessation aide * pregnant or breastfeeding

Keywords: vaccine immunogenicity randomized controlled trial addiction
hp arize 3d orthotics for planar fasciitis

Conditions: Plantar Fascitis

Summary: currently 77% of americans experience foot pain, of which a large portion can be attributed to plantar fasciitis. the arize orthotic solution, developed in collaboration with podiatrists and leading industry experts, is a new digital solution that helps podiatrists create custom foot orthoses tailored to the patient, quickly, easily, accurately, and reliably. this pilot study will evaluate the effectiveness and clinical benefit of 3d printed foot orthotics compared to traditionally fabricated custom-made orthotics and assess compliance and patient satisfaction in patients with plantar fasciitis.

currently 77% of americans experience foot pain, of which a large portion can be attributed to plantar fasciitis. approximately half of the people with foot pain do not consult a doctor due to cost, convenience, or insurance reasons. to this end, hp will implement an end-to-end system to provide 3d-printed custom orthotic inserts to patients in a fast and efficient manner via their podiatrist. the arize orthotic solution developed in collaboration with podiatrists and leading industry experts, is a new digital solution that helps podiatrists create custom foot orthoses tailored to the patient, quickly, easily, accurately, and reliably. the arize orthotic solution leverages hp 3d printing technology and aims to further hp's mission to create technology that makes life better for everyone, everywhere. this pilot study will evaluate the effectiveness and clinical benefit of 3d printed foot orthotics compared to traditionally fabricated custom-made orthotics and assess compliance and patient satisfaction in patients with plantar fasciitis.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * diagnosis of plantar fasciitis * access to methods of electronic communication (i.e., email) exclusion criteria: * previously prescribed and/or used orthotic inserts * requires additional bracing of the lower leg * diagnosis of neuropathy, acute fracture, or stress fracture * pregnant women * non-english speakers * medicare patients

Keywords: orthotics
pet imaging to delineate macrophage activation in diabetic gastroparesis

Conditions: Diabetes; Gastroparesis With Diabetes Mellitus

Summary: macrophage-driven immune dysregulation has been shown to be involved in pathophysiology of diabetic gastroparesis. currently, there are no non-invasive ways to study macrophage activation in humans. the researchers are trying to determine the utility of 11c-er176 based pet-ct scanning to determine pro-inflammatory macrophage activation in gastric wall of patients with diabetic gastroparesis.


Eligibility criteria:
inclusion criteria: * age: 18 to 70 years of age. * ability to provide informed consent. * type i or ii diabetes mellitus. * gastroparesis defined by gastric retention of tc-99m \> 60 % at 2 hrs and/or \> 10% at 4 hours on scintigraphy. * average gastroparesis cardinal symptom index (gcsi) ≥ 3 indicating moderate-severe symptoms. exclusion criteria: * women who are pregnant or cannot stop breast feeding for 24 hours. * using anti-coagulants, anti-inflammatory medications (nsaids, corticosteroids, etc.) or immunosuppressive therapies within the 4 weeks prior. * opioid use within the last 4 weeks of gastric emptying scintigraphy. * prior gastric surgery. * history of ibd, celiac disease, eosinophilic gastroenteritis, microscopic colitis. healthy subjects exclusion criteria * no clinical history of diabetes or any gi symptoms * no inflammatory disorders of the gi tract * no use of anti-inflammatory or immunosuppressive therapies

Keywords: macrophages, immune cells, gastric emptying, gastroparesis, imaging
dose-response relationship of botullinum toxin (dwp 450) for finger flexor spasticity

Conditions: Spasticity as Sequela of Stroke

Summary: study design: randomized single blind study objective: to determine the dose relationship of dwp 450 for finger flexor spasticity subjects: 78 patients with upper extremity spasticity after cva inclusion criteria: patient who have spasticity (mas greater than 2 in finger flexors) methods: patients will be randomly assigned to one of 5 groups. gp 1: placebo, gp 2: 15u, gp 3: 30 u, gp 4: 50 u, gp 5: 75 u

seventy-eight patients with upper extremity spasticity after cerebrovascular accident will be recruited and randomly assigned to one of 5 groups. the groups are as followings. gp 1: placebo group (normal saline 1.2 ml) gp 2: clostridium botulinum toxin type a (nabota, dwp 450) 15 u gp 3: clostridium botulinum toxin type a (nabota, dwp 450) 30 u gp 4: clostridium botulinum toxin type a (nabota, dwp 450) 50 u gp 5: clostridium botulinum toxin type a (nabota, dwp 450) 70 u according to the group, the injection will be performed to the finger flexor musles (flexor digitorum superficialis and profundus). outcome measurement will be mas (modified ashworth scale), fma, wolf motor assessment, cross sectional area measured by ultrasonography. patient evaluation will be conducted 2 weeks, 1 months, 2 months, and 3 months after the injection.

Eligibility criteria:
inclusion criteria: * over 6 weeks after stroke onset * mas (modified ashworth scale) greater than 2 in finger flexor exclusion criteria: * neuromuscular junction disease or motor neuron disease * phenol or alcohol block for the target limbs within 6 months before screening * botulinum toxin injection within 3 months before screening * history or plan for tendon lengthening surgery * significant contracture ormuscle atrophy at the target joint or muscle * concurrent treatment with intrathecal baclofen * hypersensitivity or allergy to study drug or its components * pregnancy or planned pregnancy, breastfeeding * abnormal lab findings for alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, and serum creatinine.
cardiac dysfunction in adolescents with type 1 diabetes: contribution of daily-life glucoregulation and impact on cardiorespiratory exercise capacity

Conditions: Diabetes Mellitus, Type 1

Summary: during the course of type 1 diabetes mellitus (t1dm), several complications can occur. one of these is the development of diastolic and systolic dysfunction (even in the absence of ischemic, valvular or hypertensive heart disease). such cardiac dysfunction and adverse remodeling is more common in adolescents with t1dm with a worse glycemic control (as evidenced by higher blood glycated hemoglobin hba1c) concentrations. even though an association has been observed between higher blood hba1c concentrations and a worse cardiac function/structure in adolescents with t1dm, less is known about the specific characteristics of the glucoregulation (e.g. number and duration of hyperglycemic or hypoglycemic episodes, age of onset of t1dm,..) in relation to cardiac function/structure in this population. therefore, the first aim of this study is to identify specific parameters related to glucoregulation which correlate with cardiac function and structure in adolescent with t1dm. in t1dm, exercise training is generally recommended and included in the guidelines for the care of t1dm (due to beneficial effects on hba1c levels, cardiovascular risk profile,..). however, as exercise training may increase the risk of hypoglycemic events, many patients may fear exercise, leading to inactivity or sedentarism. logically, physical activity volumes are diverse in cohorts of this patient population, in which the long-term physically active t1dm patient will display an optimal or preserved cardiopulmonary exercise capacity, while a suboptimal cardiopulmonary exercise capacity will be noticed in mostly sedentary t1dm patients. the second aim of this study is to evaluate the association between cardiac function/structure and cardiopulmonary exercise capacity in adolescent t1dm patients (in the perspective of their physical activity behavior). this study thus may provide greater insights in the etiology and consequences of a disturbed cardiac function/structure in adolescents with t1dm.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus exclusion criteria: * chronic diseases (except type 1 diabetes mellitus) * disorders hindering exercise
group-based peer support versus individual education for patients undergoing cpap treatment

Conditions: Sleep Apnea, Obstructive

Summary: the investigators will compare two alternatives designed to maximize adherence to continuous positive airway pressure (cpap) therapy for obstructive sleep apnea (osa) - peer-support administered in groups, versus individual education.

the study is a 6-week, open-label, parallel-arm, randomized controlled trial comparing peer support and individual education (the latter of which was designed to mimic usual care). participants in the peer-support (intervention) arm will be encouraged to attend two peer-support sessions, with one session occurring immediately prior to beginning cpap and the other occurring two weeks later. participants in the individual education (comparator) arm will begin cpap without attendance at any peer-support sessions.

Eligibility criteria:
inclusion criteria: * diagnosed with obstructive sleep apnea (no cut-off for severity) * prescribed continuous positive airway pressure exclusion criteria: * not fluent in english * prior cpap use at home * current use of any non-cpap treatment for obstructive sleep apnea * a co-morbid sleep disorder * use of supplemental oxygen * a clinical need for urgent cpap therapy
post-approval study of the tecnis symfony® toric lenses

Conditions: Cataract; Corneal Astigmatism

Summary: this study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the usa.


Eligibility criteria:
inclusion criteria: * be at least 22 years old * have cataracts in both eyes * have a certain degree of astigmatism in at least one eye * sign the written informed consent * be willing and able to comply with examination procedures * understand, read and write english to complete informed consent and questionnaires * be available for study follow-up visits both eyes must qualify to be eligible to participate in the study exclusion criteria: * currently participating in any other clinical study or have participated in a clinical study during the last 30 days * have a certain disease/illness such as poorly-controlled diabetes * have certain ocular conditions such as uncontrolled glaucoma * taking medication that may affect subject vision * have irregular corneal astigmatism * pregnant, plan to become pregnant during the study, or is breastfeeding
effects of 12-week clinical pilates exercises on mechanical low back pain

Conditions: Low Back Pain

Summary: objective: this study evaluates the effect of 12-week clinical pilates exercises on young adults with mechanical low back pain. design: this is a randomized controlled trial. setting: this study was conducted in a university's physiotherapy and exercise practice laboratory. cases: a total of 63 mechanical low back pain volunteers were included. interventions: participants were randomly assigned to the intervention group consisting of clinical pilates exercises for 12 weeks (n = 31) or the control group not receiving any treatment (n = 32).

objective: this study evaluates the effect of 12-week clinical pilates exercises on young adults with mechanical low back pain. design: this is a randomized controlled trial. setting: this study was conducted in a university's physiotherapy and exercise practice laboratory. cases: a total of 63 mechanical low back pain volunteers were included. the diagnosis of mechanical low back pain was made by a physical medicine and rehabilitation physician. exercises are performed by an experienced physiotherapist with clinical pilates certification. interventions: participants were randomly assigned to the intervention group consisting of clinical pilates exercises for 12 weeks (n = 31) or the control group not receiving any treatment (n = 32). leading measures: dysfunction was evaluated with the oswestry dysfunction index. the oswestry disability index (odi)7,9 is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. low bak pain was evaluated with the visual analog scale (vas). vas is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. the visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. and flexibility was evaluated with the sit and reach test test. the sit and reach test is a common measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles. measurements were performed at baseline and the end of the 12th week of the study.

Eligibility criteria:
inclusion criteria: * 18 to 30 years of age; who had suffered from low back pain for at least three months; who had not used medication for low back pain in the last three months; who did not have a surgical history due to spinal problems; who did not have radiculopathy or other injuries such as fractures, stenosis or tumors in the spine; who had not received any treatment related to low back within the last six months; who had not previously continued pilates exercise; and who had sufficient physical autonomy to participate in the physical activities required by the study. exclusion criteria: * volunteers who did not meet the inclusion criteria were excluded.

Keywords: clinical pilates low back pain therapeutic exercise